a. Field of the Invention
The present invention relates generally to methods for the treatment of neurological conditions, and, more particularly, to a method for alleviating/controlling symptoms associated with neurodegeneration and similar conditions stemming from multiple sclerosis, aging, autoimmune diseases and other causes, by administration of compositions which induce an increased presence of histamine H2 and cyclic AMP in the body.
b. Related Art
Neurodegenerative conditions, which include diseases of autoimmunity, strike an increasing number of individuals each year, and for many of these conditions conventional treatments offer little in the way of true relief. In some instances, the neurodegenerative conditions are more or less specifically associated with a particular disease, such as multiple sclerosis, while in other instances the conditions are associated more generally with aging or some other condition or process of the body, such as a genetic disorder or an autoimmune disease, fibromyalgia, for example. As a group, however, these conditions are characterized by weakness and impaired physical functions, and, sometimes, impaired mental functions as well. Debilitation is often progressive, and, as stated, conventional treatments and therapies have been limited in their success.
For purposes of illustration the invention will be described below largely in the context of multiple sclerosis, which is a condition to which the invention has particular applicability; however, it will be understood that the present invention is applicable to neurodegenerative conditions, including autoimmune diseases, fibromyalgia, having any of a variety of sources, therefore it is not limited in scope to the treatment of multiple sclerosis alone.
As is known, multiple sclerosis (referred to from time-to-time hereinafter as “MS”) is a chronic degenerative disease of the central nervous system, characterized by demyelination of the nerve axons. Symptoms include varying degrees of fatigue, numbness, tremors/muscle spasms and paralysis, coupled with a heightened susceptibility to heat and other environmental stressors. Currently, approximately 2,500,000 people worldwide have been diagnosed as having multiple sclerosis. Onset of the disease usually occurs between 20 and 40 years of age.
It is recognized that MS occurs in at least two general types, i.e., “remissive-relapsive”, in which acute exacerbations are separated by periods of partial recovery, and “chronic-progressive”, in which the symptoms continue generally unrelieved and there is a progressive deterioration of the patient's condition that may eventually result in total debilitation.
Efforts at treatment of MS have heretofore concentrated almost entirely on the body's autoimmune response system. The prevailing theory has been that some agent causes the myelin sheath to be attacked by the immune system, resulting in destruction of the myelin and creation of lesions. It is also believed that certain viruses may play a role in causing or precipitating MS: In particular, the measles virus may be involved in the disease, in that studies have not only found that people suffering from MS almost invariably possess the measles antigen, but also that MS patients generally have higher than normal levels of measles antibodies in their serum and cerebrospinal fluid. One theory has been that the measles or other virus triggers the T-cells to attack and destroy the myelin sheath.
Proceeding on the theory that MS is the result of an autoimmune response triggered by measles or another virus, most conventional treatment techniques have involved the use of Betaseron, Avonex and/or other anti-viral substances, generally referred to collectively as “Interferon”. The intended purpose of these materials is to impede the RNA-DNA transcription process in the T-cells, which is believed to be triggered by the virus attacking the myelin. While interferon has demonstrated some positive results when treating remissive-relapsive type MS, it has proven almost entirely ineffective against the chronic-progressive type.
Another treatment method that has yielded a limited degree of success involves the injection of adenosine monophosphate. This material is not readily absorbed, in part because it is ordinarily available only in an oil-based solution, and is not “friendly” to the patient's tissues. The tissues have a tendency to wall off the material and form a small abscess capsule around it, and with each injection the material becomes harder and harder to absorb. In order for the material to be absorbed, most patients must walk vigorously on a treadmill for 20-30 minutes or engage in other strenuous exercise, or else the material will simply remain at the injection site with the result that the patient becomes extremely sore and the symptoms do not improve. Most people suffering from MS, however, are not mobile and are simply incapable of engaging in such exercise. Consequently, while many individuals experience significant benefits at the beginning of adenosine monophosphate treatments, these results eventually fade as the person's body becomes unable to absorb the material.
As will be described in greater detail below, the present invention is not postulated on conventional autoimmune theories, and instead enhances neuronal metabolism of histamine to its H2 agonist in order to prevent/repair self-degeneration of the myelin. With the exception of experimental studies by Hinton D. Jonez, M.D. (Jonez, “Management of Multiple Sclerosis”, Postgraduate Medicine, May 1952) and certain methods described in patents to John McMichael (U.S. Pat. Nos. 4,521,405 and 4,705,685), histamine phosphate (which is most commonly employed for diagnosis of stomach conditions) has not been used in connection with multiple sclerosis and related disorders.
The work of both Jonez and McMichael is founded on conventional autoimmune response theories. Dr. Jonez's experiments in the early 1950's attempted to manipulate the body's allergic responses using histamine phosphate, and also used the material as a vasodilator to get more blood to the brain and other parts of the nervous system. In this context, it should be understood that the present invention employs histamine phosphate to mimic histamine H2, the functions of which are confined mainly to the central nervous system, whereas the primary agent in allergic reactions is histamine H1. At the time of Dr. Jonez's work, however, this distinction (between histamine H1 and histamine H2) was not fully appreciated.
McMichael's method involves the injection of a small amount of an “immunogen” consisting of viral fragments or other antigens (under the theory known as “provocative neutralization”), together with a small amount of histamine phosphate. McMichael identifies histamine phosphate as a vasodilator, and theorizes that the histamine phosphate reacts with the immunogen to form an “active complex” which affects absorption of the material. In any event, the amounts of histamine phosphate that are involved in McMichael's treatment are far too small to have any significant impact on overall levels of histamine H2 in the body.
As was noted above, many other neurodegenerative conditions besides MS are widespread in the population. Many of these conditions are associated with the aging process and are therefore becoming increasingly common as the numbers of elderly increase in the United States and many other countries. Some of these conditions have been conventionally approached on a similar basis to the autoimmune theories described above, and again with limited success. Most other approaches have been similarly disappointing, and in many instances progression of the neurodegenerative conditions has simply been accepted as inevitable.
Accordingly, there exists a need for a treatment method that effectively alleviates the symptoms of multiple sclerosis and other neurodegenerative disease conditions. Furthermore, in the specific case of MS, there exists a need for such a method that provides an effective treatment for both the remissive-relapsive and chronic-progressive forms of the disease. Still further, there exists a need for such a method in which the treatment compositions are readily absorbed into the patient's body, without requiring resort to physical exercise for effective absorption. Still further, there exists a need for such a method that is sufficiently economical to be widely available to the large number of individuals who suffer from MS and other neurodegenerative diseases.